Tuesday, June 11, 2013

Should the Pill Be Accessible Without a Prescription?

A small Pennsylvania college made national headlines recently for putting packs of the emergency contraceptive Plan B in a vending machine in their student health center. Imagine the uproar if that vending machine had packs of the pill in it, too. Selling the pill in a vending machine wouldn’t be legal in the U.S., but the idea raises an interesting question about how accessible oral contraceptives should be.

Is it dangerous to sell the pill over- or behind-the-counter?

Doctors have argued since 1968 that the pill can safely be sold over-the-counter (OTC). That means rather than go to a doctor or clinic for a prescription, a woman could go to a drug store to pick up a pack of pills in the same way she can now buy aspirin. Behind-the-counter means a woman would ask a pharmacist for the pill, but she still wouldn’t need a prescription from a doctor. Over 50 drugs that were once prescription-only are now OTC in the U.S., including Sudafed, Cortaid, Advil, Nyquil, Monistat, and Claritin.

The pill doesn’t have much in common with other prescription-only drugs:

It’s not addictive (unlike cigarettes that are sold in vending machines).

Taking too many pills might make you throw up, but it doesn’t cause a deadly overdose (unlike the acetaminophen that is on the shelves of every drug store).

All brands of the pill work without fine-tuning the dose with the help of a doctor.

Taking the pill for a year results in long-term health benefits, including protection from cancer of the uterus or ovary.

The pill is for women (or couples) who’ve decided they want to avoid pregnancy—no need for a diagnosis from a health care provider.

There’s a lot of misinformation about the safety of the pill. In fact, women in over 80 countries can already buy it without a prescription—including women just across the border in Mexico.* As medications go, the pill is very safe—safer than having a baby, driving, smoking, or taking daily aspirin. That said, the pill does have risks for women with certain medical conditions; if it were sold OTC, could women correctly decide whether it would be a good option for them? One study in El Paso showed that women who answered 15 questions were pretty accurate in choosing whether the pill was safe for them. The study asked a nurse to decide if the same women could safely use the pill, and compared the answers of the women and the nurse. For all but two of the questions, women and the nurse agreed nearly all of the time (98%).

The questions they didn’t agree on were about blood pressure and migraine headaches, the two most common health conditions that make the pill less safe—both in this study and in real life.

1. High blood pressure. Some of the women in the study didn’t know they had high blood pressure. It becomes more common as people get older, so older women were more likely than young women to have undiagnosed high blood pressure. These women thought they could use the pill, but the nurse said they shouldn’t.

2. Migraine headaches with changes in vision, hearing and motion. Young women tend to experience more migraine headaches than women in their 30s. Only one very specific type of migraine makes the pill less safe, called migraine with aura. (In this case “aura” means changes in vision, hearing or motion.) Women who had migraines without aura sometimes thought they could not use the pill, but the nurse said they’d be able to.

This is where a pharmacist could come in if the pill were sold behind-the-counter. Pharmacists help people take medications safely, and they could check a woman’s blood pressure and help diagnose the different types of migraines. A study in Seattle showed that women liked getting the pill directly from a pharmacist, and pharmacists liked being able to offer it. But there was a catch: zero insurance companies agreed to pay the pharmacists for their time, so women had to pay for the pharmacy consultation out-of-pocket.

The 15 Questions

If you answer “yes” to any of these questions, talk with a health care provider before using the pill:

1. Are you a smoker age 35 or older?

2. Do you think you might be pregnant?

3. Have you had a baby in the past 3 weeks?

4. Are you currently breastfeeding and is your baby less than 6 months old?

5. Do you have high blood pressure?

6. Have you had a heart attack or stroke?

7. Do you have heart disease?

8. Have you had a blood clot (thrombosis) in your lung or in your leg (NOT just varicose veins)?

9. Do you have diabetes?

10. Do you have migraine headaches?

11. Do you have liver disease or have you had liver cancer?

12. Do you have gall bladder disease?

13. Have you had breast cancer?

14. Do you take medicine for high cholesterol?

15. Do you take medicine for seizures or tuberculosis (TB)?

Would women buy the pill OTC?

A nationwide survey of reproductive-age women in the U.S. found that over two-thirds (68%) would buy contraceptives from a pharmacist and skip the doctor’s appointment. Women with lower incomes and women without health insurance were particularly interested in this option. Clearly, getting to and paying for clinic visits can make accessing prescription-only pills more hassle than it’s worth for some women. The majority of women surveyed agreed that the pill should be available without a prescription if a pharmacist would help women decide whether it was safe for them.

Women in other countries have been buying the pill OTC from pharmacies or community distribution centers for decades. So, are they more likely than women who get the pill by prescription to use it when it’s not safe for them? One study compared women in Mexico who got the pill from a clinic versus those who got it from a pharmacy and found no difference between the two groups—a small percentage of women in both groups (2%) shouldn’t have been using the pill. That suggests going to a clinic doesn’t guarantee that women are screened for health conditions before getting the pill.

And screening seems to be skipped in the U.S., too. A national study showed that 6% of U.S. women who use the pill probably shouldn’t. In this study, the majority of women who shouldn’t have been using the pill were over 35 and smoked heavily, or had a history of breast, cervical, or uterine cancer. Ironically, selling the pill behind-the-counter with pharmacists trained to screen women for safe pill use could ensure that fewer women slip through the screening cracks.

If this is such a great idea, why hasn’t it happened yet?

There is one potential downside to selling the pill OTC. Some women now have access to free or low cost prescription pills via Medicaid and private health insurance. Health insurance doesn’t typically cover OTC drugs like ibuprofen and cough syrup. If the pill were sold OTC, women now covered by Medicaid—who most need affordable methods of birth control—could be faced with higher prices. But there are several ways to address this problem:

In some states, Medicaid covers existing OTC methods like condoms, and this coverage could be expanded to OTC pills.

Not all brands of the pill would make the switch to being sold OTC at once, and it’s likely that at least some of the prescription-only brands would still be covered by Medicaid and private health insurance.

There is another potential downside that some people talk about, but it’s actually a red herring. The argument is that the pill should stay prescription-only because it reinforces yearly Pap tests and pelvic exams for women. The truth is that neither of these tests is required to use the pill. As Dr. David Grimes wrote in 1995, “women should not have contraception held hostage because of unrelated screening tests.” Despite that, many health care providers still require the tests before prescribing the pill, and the majority aren’t using the new national guidelines that call for less frequent Pap tests. The final nail in the coffin of this argument is that there is no evidence that women who use OTC birth control stop going to clinics or doctors for care.

Ultimately, the U.S. Food and Drug Administration (FDA) will make the decision about whether the pill can be sold OTC. The FDA makes this type of change for one brand of pill at a time, and there are over 100 brands of pill now sold in the U.S. Dr. Dan Grossman—a leader of a group of health researchers, advocates, nurses and doctors who argue for switching the pill to OTC—says that to switch, a drug company that makes an FDA-approved pill would have to support two new studies: one showing that women can understand the instructions for taking an OTC pill and one showing “women can appropriately self-select themselves as candidates for the pill and that they can use it safely and effectively for some period of time.” The process will be expensive: someone will have to ante up about $10,000,000 for the two studies. So far, no pill manufacturers or funders have stepped forward.

Making birth control available without a prescription has happened once before: the FDA decided thatemergency contraceptive pillscould be sold behind-the-counter to anyone 17 or older—although it took years and a court caseto make that decision final. The only ingredient of the emergency contraceptive pills Plan B and Next Choice is a progestin. The exact same ingredient is in some brands of progestin-only or mini-pills. The mini-pill is safe for almost all women, including those with high blood pressure and migraines with aura.It could be that a mini-pill will be availablewithout a prescription in the U.S. before a combined hormonal contraceptive pill… Don’t worry, there’s no way you could miss news of any kind of birth control pill going OTC—a hullabaloo is guaranteed, whether a vending machine is involved or not.

*If the pill’s so safe, why’s it prescription-only now? (Or, a quick history of birth control in the U.S., from “lewd and lascivious” to “therapeutic”)

Birth control has a unique history in the United States and the pill was not available here until 1960. By that time, birth control was already firmly the domain of doctors. Nearly a century earlier, in 1873, the Comstock Act had made birth control—and even information about birth control—illegal in the U.S., declaring it obscene and making it a federal offense to distribute birth control in the mail or between states.

Over the next century, this national law and 30 similar state laws were gradually challenged and overturned in courts. One major legal victory over the Comstock Act came with the 1936 U.S. Circuit Court of Appeals decision on United States v. One Package. That decision made it legal for doctors to distribute birth control across state lines. The same year, the American Medical Association recognized that providing birth control was part of a physician’s role. Doctors slowly started offering information and methods of birth control over the next few decades, and some were key players in the legal fight against state Comstock laws.

In 1957, the U.S. Food and Drug Administration (FDA) approved the first pill for therapeutic purposes only—to treat severe menstrual disorders—and not for birth control. Doctors began prescribing it and learned that there was a huge demand for the pill. When the FDA finally approved the pill for birth control in 1960, it was also prescription-only. At the time, that made good sense. It was a new kind of medication, and one that would be taken by healthy women. Following in the footsteps of the pill, all but a few modern methods of birth control are prescription-only. (The exceptions are condoms, spermicides, the sponge, and emergency contraception for women over age 17.)